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PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory
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PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Apr 01, 2015

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Page 1: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

PT Program

Kirstin McCracken, TNI PT Committee ChairQuality Assurance ManagerTestAmerica, Burlington Laboratory

Page 2: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Today’s Session

PT Standard TIA Recap PT Frequency Update

Page 3: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

TIA Recap

The PT Committee issued 6 TIA for public comment earlier this summer.

5 TIA were made to bring consistency between V1M2 and V2M2

1 TIA was issued for V3 to correct an error that was overlooked during standards development

Page 4: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

PT Frequency Update Background & Recap PT Frequency Subcommittee PT Committee Vote

Page 5: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Background and Recap History

Hold for Next Revision Comments

LASC White Paper – Newport Beach

Request from Advocacy Committee

Page 6: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Rationale for Change

Costs of PT 2X per Year exceeds benefits to lab performance

TNI PT Frequency is primary barrier to expansion of national accreditation

TNI PT Frequency is out of line with Federal Program Requirements, specifically, USEPA Drinking Water Program

There is no real difference between WP & WS PT matrices; methodology and technology are equivalent.

Page 7: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

PT Frequency Subcommittee

Established by PT Committee in Spring 2008

Subcommittee Chair- Dan Tholen

10 Subcommittee & Associate Members 1 NELAC AB2 EPA 1 Consultant2 PT Providers4 Lab

Page 8: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

PT Frequency Subcommittee

NJ Data Study- published on TNI website AB Survey Lab Survey All State Data Study PT Frequency Subcommittee Report

Report Completed August 3, 20098 Conclusions , 1 Recommendation

Page 9: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Subcommittee Conclusions

Labs that take more PT may have better performance – but cannot isolate frequency from other factors such as quality system

Data reviewed did not support any proposed theory for difference in laboratory performance and PT

PT Frequency is not the sole barrier for attracting more AB Authoritative Association of Scientists (IUPAC) recommend 2 PT per year Other Federal Agencies (DOE, DoD) require 2 PT per year External publications show more frequent PT equals better lab

performance Economic impact of a reduction in PT frequency is difficult to determine

with available information. International efforts for PT frequency is based on individual laboratories

Based on current information available, there is no compelling reason to support a change to the current PT Frequency requirement in the TNI Standard

Page 10: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

PT Committee Vote

Hold for Next Revision Comments under consideration:

Reduce Frequency from 2 to 1 PT per Year Combine WP & WS into 1 Study

Is the rationale for change substantiated by the data studies and surveys conducted by the subcommittee; the White Papers and other reference information reviewed by the committee; and by the public debate that has occurred in support of or against a change?

Page 11: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

PT Committee Vote

Decision Type: High Stakes / Confidential

Decision Making Rule:Enthusiastic Support (80% Affirmative)

For a comment to be found persuasive; 7 out of 9 committee members must vote affirmatively.

Page 12: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

PT Committee Structure

4 Laboratories 2 Large Commercial, 1 Municipal, 1

Captive 2 AB

1 NELAC AB, 1 Non-NELAC AB 3 Other

1 PTOB/PTPA 2 PT Provider

Page 13: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Negative Vote Rationale The rationale that reduction in PT Frequency

would attract more participating ABs and Labs is speculative and cannot be substantiated with current information available.

Rationale to combine WP & WS into a single aqueous PT with the most stringent concentration range and acceptance criteria would create unnecessary burden on many laboratories; methodology between WP & WS is not equivalent for all parameters.

Page 14: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Vote Tally

Comment # # Affirmative # Negative Outcome

Comment 122 4 5 Not Persuasive

Comment 203 1 8 Not Persuasive

Comment 225 4 5 Not Persuasive

Comment 312 4 5 Not Persuasive

Comment 331 5 4 Not Persuasive

Comment 227 4 5 Not Persuasive

Page 15: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Next Steps

Post PT Frequency Subcommittee report on TNI Website along with survey and data studies.

Committee to review vote comments, prepare formal response to comments found not persuasive.

Page 16: PT Program Kirstin McCracken, TNI PT Committee Chair Quality Assurance Manager TestAmerica, Burlington Laboratory.

Conclusion

TNI is a consensus based standard; by consensus the TNI membership must establish the purpose of PT and then determine the best PT scheme to achieve that purpose.

We need to hear from you-all of you.